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一项双盲、安慰剂对照、随机临床试验,评估在经皮肾镜取石术中冲洗液中使用氨甲环酸对出血量的疗效:来自印度北部三级护理中心的初步研究。

A double-blind, placebo-controlled randomized clinical trial to evaluate the efficacy of tranexamic acid in irrigant solution on blood loss during percutaneous nephrolithotomy: a pilot study from tertiary care center of North India.

机构信息

Janak Surgicare Centre, Patiala, Punjab, India.

出版信息

World J Urol. 2017 Aug;35(8):1233-1240. doi: 10.1007/s00345-016-1980-6. Epub 2016 Dec 19.

DOI:10.1007/s00345-016-1980-6
PMID:27995302
Abstract

PURPOSE

To evaluate the efficacy and safety of 0.1% tranexamic acid in irrigant fluid in reducing blood loss during PCNL.

MATERIALS AND METHODS

The study involved 400 patients who were planned for PCNL and were prospectively randomized into two equal groups. In tranexamic group, 0.1% tranexamic acid was given in irrigant fluid, while in placebo group, distilled water was added to irrigant fluid during surgery. Operative data were recorded which included fall in hemoglobin, total blood loss, operative time, irrigation fluid, length of stay in hospital, requirement of blood transfusion, complications related to PCNL and adverse events of tranexamic acid.

RESULTS

Baseline parameters were comparable between two groups. The fall in hemoglobin and total blood loss in the tranexamic group was significantly lower than placebo group (1.71 vs. 2.67 gm/dL, 154.55 vs. 212.61 mL, respectively, p < 0.0001). Operative time, amount of irrigation fluid used and hospital stay of tranexamic group were significantly less compared to placebo (p < 0.05). Complete stone clearance rate was 88% in tranexamic group versus 82% in placebo (p = 0.12). The blood transfusion requirement was significantly lower in the tranexamic group versus placebo (5 vs. 12.5%, p = 0.012), as was the complication rate (19 vs. 28%, p = 0.044). The requirement of angioembolization in the tranexamic group was significantly less as compared to placebo (0.5 vs. 4%, p = 0.03). No adverse events related to administration of tranexamic acid were noted.

CONCLUSIONS

0.1% tranexamic acid in irrigant fluid is safe and significantly reduces perioperative blood loss and requirement of blood transfusion during percutaneous nephrolithotomy. It is associated with lower perioperative complication rates.

摘要

目的

评估在经皮肾镜取石术中应用 0.1%氨甲环酸冲洗液减少术中失血的疗效和安全性。

材料和方法

本研究纳入了 400 例计划行 PCNL 的患者,前瞻性随机分为两组。在氨甲环酸组中,在冲洗液中加入 0.1%氨甲环酸,而在安慰剂组中,手术中向冲洗液中加入蒸馏水。记录手术数据,包括血红蛋白下降量、总失血量、手术时间、冲洗液量、住院时间、输血需求、与 PCNL 相关的并发症以及氨甲环酸的不良反应。

结果

两组的基线参数相当。氨甲环酸组的血红蛋白下降量和总失血量明显低于安慰剂组(分别为 1.71 与 2.67 g/dL、154.55 与 212.61 mL,p<0.0001)。氨甲环酸组的手术时间、冲洗液用量和住院时间明显少于安慰剂组(p<0.05)。氨甲环酸组的完全结石清除率为 88%,安慰剂组为 82%(p=0.12)。氨甲环酸组的输血需求明显低于安慰剂组(5%与 12.5%,p=0.012),并发症发生率也较低(19%与 28%,p=0.044)。氨甲环酸组的血管栓塞需求明显低于安慰剂组(0.5%与 4%,p=0.03)。未观察到与氨甲环酸给药相关的不良反应。

结论

在经皮肾镜取石术中应用 0.1%氨甲环酸冲洗液安全有效,可显著减少围手术期失血和输血需求,并降低围手术期并发症发生率。

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